MAUDE Adverse Event Report: THINK SURGICAL, INC TMINI MINIATURE ROBOTIC SYSTEM; STEROTAXIC ORTHOPEDIC INSTRUMENTATION

Model Number	109343
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was a cut error of 3.4 degrees following cuts performed using the timini system during tka surgery.The surgeon noticed the cut error and performed a manual cut using the implant manufacturers 2 degree valgus cut block.The final cut error comparing the surgical plan with the post operative x-ray shows 1.4 degrees of varus.Registration was performed and registration points were collected correctly on bone surface per the instructions for use, and therefore, the cut error was not associated with the registration process.Based on the user requirements the surgeon needs to be able to perform tka with an accuracy in the coronal alignment of the tibial component within 3° rmse of a surgical plan.The system did not perform within the user needs given that the pre-corrected alignment was off by 3.4 degrees of varus error.At this time the root cause has not been determined and the investigation is on-going.There was no patient harm reported.
Event or Problem Description
During a surgical procedure of the left knee, after performing the tibial cut with the tmini, the surgeon fel that the cut was more varus than planned and that the lateral tibial resection was "under resected" the surgeon then manually resected more of the lateral proximal tibia.

• Brand Name: TMINI MINIATURE ROBOTIC SYSTEM
• Common Device Name: STEROTAXIC ORTHOPEDIC INSTRUMENTATION
• Manufacturer (Section D): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer (Section G): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer Contact: denise duchene ; 47201 lakeview blvd; fremont, CA 94538 ; 8604815113
• MDR Report Key: 21267316
• Report Number: 3000719653-2025-00001
• Device Sequence Number: 8533466
• Product Code: OLO
• UDI-Device Identifier: M9461093430
• UDI-Public: M9461093430
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K243285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 109343
• Device Catalogue Number: 109343
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown